Pharmacokinetics of Irbesartan High/Amlodipine FDC and Co-administration of Irbesartan High and Amlodipine in Healthy Volunteers

Phase 1

Completed

• Conditions: Healthy Volunteers
• Interventions: Drug: Irbesartan High/Amlodipine FDC; Drug: Irbesartan High; Drug: Amlodipine

• Registration Number: NCT05688085
• Lead Sponsor: Handok Inc.

Brief Summary

The purpose of this study is to compare pharmacokinetics and safety of Irbesartan High and Amlodipine Fixed Dose Combination and coadministration of mono compounds in healthy adult volunteers

Detailed Description

Not available

Study Timeline

• Study Start: 2022-10-18
• Primary Completion: 2022-12-29
• Study First Submitted: 2023-01-08
• Study First Submitted QC: 2023-01-08
• Study First Posted: 2023-01-18
• Study Completion: 2023-04-21
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-15
• Last Update Posted: 2023-08-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 44

Inclusion Criteria

• Patients who are 19 years or older on screening
• Signed informed consent
• Healthy Volunteer
• Other inclusion applied

Exclusion Criteria

• Clinically relevant/significant findings as evaluated by the investigator
• Other exclusion applied

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Co-administration of Irbesartan High and Amlodipine	Amlodipine	participants will receive one table each of Irbesartan High and Amlodipine in a crossover design
Irbesartan High/Amlodipine Fixed dose combination	Irbesartan High/Amlodipine FDC	participants will receive one tablet of Irbesartan High/Amlodipine FDC in a crossover design
Co-administration of Irbesartan High and Amlodipine	Irbesartan High	participants will receive one table each of Irbesartan High and Amlodipine in a crossover design

Primary Outcome Measures

Name	Time	Method
AUCt of Irbesartan High and Amlodipine	72 hours
Cmax of Irbesartan High and Amlodipine	72 hours

Secondary Outcome Measures

Name	Time	Method
AUCinf of Irbesartan High and Amlodipine	72 hours
tmax of Irbesartan High and Amlodipine	72 hours
Vz/F of Irbesartan High and Amlodipine	72 hours
AUCt/AUCinf of Irbesartan High and Amlodipine	72 hours
half-life of Irbesartan High and Amlodipine	72 hours
CL/F of Irbesartan High and Amlodipine	72 hours

Trial Locations

Locations (1)

H Plus Yangji Hospital; 🇰🇷 Seoul, Korea, Republic of